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First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Study of SAR443579 infusion for certain blood cancers in children and adults.

Recruiting
1 years and older
All
Phase 1/2
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study tests a new drug, SAR443579, for people with certain blood cancers like Acute Myeloid Leukemia (AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), and others. The study is called "first-in-human" because it's the first time this drug is being tested in humans. It is an open-label study, meaning everyone knows the treatment being given. The study will last about 2.5 years for each participant.

Participants must be at least 1 year old, or 2 years in France, and have specific types of blood cancers that haven't responded to other treatments. Some people cannot participate, like those with other serious health conditions or who are pregnant.

  • Study Length: 2.5 years involvement.
  • Eligibility: Must have certain blood cancers and no other treatment options.
  • Participation: Not allowed if pregnant or have certain health conditions.

Consider if you meet the requirements and are willing to commit to a long study period. Participating could help find new treatments for tough-to-treat blood cancers.

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Study details
    Acute Lymphocytic Leukaemia
    Acute Myeloid Leukaemia Refractory
    Myelodysplastic Syndromes
    Blastic Plasmacytoid Dendritic Cell Neoplasia

NCT05086315

Sanofi

1 February 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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